Nonwoven tissue scaffold

• US 8,137,686 B2
• Filed: 04/20/2004
• Issued: 03/20/2012
• Est. Priority Date: 04/20/2004
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Inventors: Kladakis, Stephanie M., Hammer, Joseph J., Shetty, Dhanuraj, Dhanaraj, Sridevi
• Primary Examiner(s): WOODWARD, CHERIE MICHELLE
• Application Number:
  US10/828,838
• Publication Number:
  US 20050232967A1
• Time in Patent Office: 2,891 Days
• Field of Search: None
• US Class Current: 424/423
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61L 2430/06 for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A biocompatible meniscal repair device is disclosed. The tissue repair device includes a scaffold adapted to be placed in contact with a defect in a meniscus, the scaffold comprising a high-density, dry laid nonwoven polymeric material and a biocompatible foam. The scaffold provides increased suture pull-out strength.

Claims

1. A biocompatible meniscal repair device, comprising;

a biocompatible tissue repair scaffold adapted to be placed in contact with a defect in a meniscus, wherein the scaffold comprises a dry laid nonwoven polymeric material, the dry laid nonwoven polymeric material consists of a density in the range of about 120 mg/cc to 360 mg/cc, and wherein the scaffold has an initial modulus of elasticity greater than 1.5 MPa or about 1.5 MPa and an initial suture pull-out strength greater than 6 N or about 6 N, and wherein viable tissue is disposed on the tissue repair scaffold, the viable tissue having viable cells capable of integrating with native tissue adjacent to the tissue repair scaffold.

2. The repair device of claim 1, wherein the tissue repair scaffold has an initial peak stress greater than about 2 MPa.

3. The repair device of claim 1, wherein the tissue repair scaffold has an initial suture pull-out strength less than about 45 N.

4. The repair device of claim 1, wherein the tissue repair scaffold has an initial modulus of elasticity less than about 40 MPa.

5. The repair device of claim 1, wherein the tissue repair scaffold has a thickness in the range of about 0.5 mm to 1.5 mm.

6. The repair device of claim 1, wherein the tissue repair scaffold further comprises a biocompatible foam material joined to the nonwoven polymeric material.

7. The repair device of claim 1, the nonwoven polymeric material comprises a synthetic polymer.

8. The repair device of claim 1, wherein the tissue repair scaffold is bioabsorbable.

9. The repair device of claim 1, wherein the nonwoven polymeric material is formed from at least one polymer derived from monomers selected from the group consisting of glycolide, lactide, caprolactone, trimethylene carbonate, polyvinyl alcohol, and dioxanone.

10. The repair device of claim 9, wherein the nonwoven polymeric material comprises polydioxanone.

11. The repair device of claim 9, wherein the nonwoven polymeric material comprises a copolymer of polyglycolic acid and polylactic acid.

12. The repair device of claim 1, further comprising at least one bioactive substance effective to stimulate cell growth.

13. The repair device of claim 12, wherein the bioactive substance is selected from the group consisting of a platelet rich plasma, cartilage-derived morphogenic proteins, recombinant human growth factors, and combinations thereof.

14. The repair device of claim 1, wherein the nonwoven polymeric material comprises crimped, synthetic polymer fibers.

15. The repair device of claim 1, wherein the nonwoven polymeric material is heat-set.

16. The repair device of claim 1, wherein the fiber orientation of the nonwoven polymeric material is isotropic.

18. The repair device of claim 1, wherein the viable tissue disposed on the tissue repair scaffold is selected from the group consisting of minced tissue, sliced tissue, and a tissue strip.

17. A biocompatible meniscal repair device, comprising

a biocompatible tissue repair scaffold adapted to be placed in contact with a defect in a meniscus, the scaffold including:

(a) a dry laid nonwoven polymeric material consisting of a density in the range of about 120 mg/cc to 360 mg/cc;

(b) a biocompatible foam; and

(c) viable tissue disposed on the tissue repair scaffold, the viable tissue containing viable cells capable of integrating with native tissue adjacent to the tissue repair scaffold,

wherein, the scaffold provides increased suture pull-out strength and has an initial modulus of elasticity in the range of about 1.5 MPa to 40 MPa.

19. The repair device of claim 17, wherein the tissue repair scaffold has a peak stress in the range of about 2 MPa to 14 MPa.

20. The repair device of claim 17, wherein the tissue repair scaffold has a suture pull -out strength in the range of about 6 N to 45 N.

21. The repair device of claim 17, wherein the tissue repair scaffold has a thickness in the range of about 0.5 mm to 1.5 mm.

22. The repair device of claim 17, the nonwoven polymeric material comprises a synthetic polymer.

23. The repair device of claim 17, wherein the tissue repair scaffold is bioabsorbable.

24. The repair device of claim 17, further comprising at least one bioactive substance effective to stimulate cell growth.

25. The repair device of claim 24, wherein the bioactive substance is selected from the group consisting of a platelet rich plasma, cartilage-derived morphogenic proteins, recombinant human growth factors, and combinations thereof.

26. The repair device of claim 17, wherein the viable tissue disposed on the tissue repair scaffold is selected from the group consisting of minced tissue, sliced tissue, and a tissue strip.